Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.
KRN125 is administered as a single SC dose to the Day 1. The stem cell mobilization protocols will be monitored for safety and efficacy during the mobilization period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Single dose of SC administration
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7
Time frame: Baseline to Day 7
• Period from baseline to first time peripheral blood CD34 positive cells >20 cells/μL
Time frame: Baseline to Day 15 or through study completion, an average of 1 year
• Time from baseline to peak peripheral blood CD34 positive cells
Time frame: Baseline to Day 15 or through study completion, an average of 1 year
• Achievement of >10 cells/μL positive for CD34 in peripheral blood from baseline to Day 7
Time frame: Baseline to Day 7
• Peripheral blood CD34 positive cell count
Time frame: Baseline to Day 15 or through study completion, an average of 1 year
• Peripheral blood white blood cell count
Time frame: Baseline to Day 15 or through study completion, an average of 1 year
• Peripheral blood neutrophil count
Time frame: Baseline to Day 15 or through study completion, an average of 1 year
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